Trial Outcomes & Findings for Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED) (NCT NCT00289874)
NCT ID: NCT00289874
Last Updated: 2022-02-02
Results Overview
Percent change from baseline in FEV1, a measure of airway function, at Week 3
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
421 participants
Primary outcome timeframe
Baseline and week 3
Results posted on
2022-02-02
Participant Flow
One hundred three sites in US; Prime Therapy: March 2006 to July 2007
Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.
Participant milestones
| Measure |
Montelukast 5 mg
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
|
Placebo
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
218
|
|
Overall Study
COMPLETED
|
197
|
210
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Montelukast 5 mg
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
|
Placebo
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Did not meet eligibility
|
1
|
0
|
Baseline Characteristics
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Montelukast 5 mg
n=203 Participants
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
|
Placebo
n=218 Participants
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
|
Total
n=421 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.6 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
10.6 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Daily β-agonist use
|
3.01 Puffs/Day
STANDARD_DEVIATION 1.77 • n=5 Participants
|
2.72 Puffs/Day
STANDARD_DEVIATION 1.68 • n=7 Participants
|
2.86 Puffs/Day
STANDARD_DEVIATION 1.73 • n=5 Participants
|
|
Forced expiratory volume in 1 second (FEV1)
|
1.81 Liters
STANDARD_DEVIATION 0.57 • n=5 Participants
|
1.84 Liters
STANDARD_DEVIATION 0.60 • n=7 Participants
|
1.83 Liters
STANDARD_DEVIATION 0.58 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 3Population: The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).
Percent change from baseline in FEV1, a measure of airway function, at Week 3
Outcome measures
| Measure |
Montelukast 5 mg
n=199 Participants
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
|
Placebo
n=208 Participants
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
|
9.53 Percent Change
Interval 7.05 to 12.01
|
9.15 Percent Change
Interval 6.71 to 11.59
|
SECONDARY outcome
Timeframe: Baseline and Week 3Population: The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).
Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Outcome measures
| Measure |
Montelukast 5 mg
n=198 Participants
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
|
Placebo
n=212 Participants
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period
|
-18.88 Percent Change
Standard Deviation 84.75
|
-12.40 Percent Change
Standard Deviation 53.88
|
Adverse Events
Montelukast 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast 5 mg
n=203 participants at risk
Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
|
Placebo
n=217 participants at risk
Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/203 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.46%
1/217 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/203 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.46%
1/217 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/203 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.92%
2/217 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/203 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.46%
1/217 • Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast \& 217 placebo) is the number that received treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER